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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, electrical, implanted, for parkinsonian tremor
Product CodeMHY
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
36 34 31 47 44 17

MDR Year MDR Reports MDR Events
2021 2427 2436
2022 2259 2267
2023 3489 3493
2024 4388 4395
2025 3428 3428
2026 1626 1626

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3634 3644
Connection Problem 2502 2503
High impedance 2494 2497
Material Integrity Problem 2203 2204
Battery Problem 2101 2104
Insufficient Device Problem Information 1354 1354
Charging Problem 1268 1268
Failure to Deliver Energy 1048 1048
Communication or Transmission Problem 812 812
Failure to Power Up 716 716
Break 663 663
Low impedance 620 620
Impedance Problem 540 540
Display or Visual Feedback Problem 534 534
Inappropriate/Inadequate Shock/Stimulation 472 472
Failure to Interrogate 471 471
Therapeutic or Diagnostic Output Failure 373 373
Energy Output Problem 346 346
Improper or Incorrect Procedure or Method 340 340
Migration or Expulsion of Device 337 337
Electromagnetic Compatibility Problem 310 310
Premature Discharge of Battery 290 290
Malposition of Device 274 274
Material Twisted/Bent 237 238
Delayed Charge Time 233 233
Unintended Collision 222 222
Unexpected Therapeutic Results 213 215
Material Deformation 208 208
Unstable 193 193
Wireless Communication Problem 192 192
Fracture 191 192
Operating System Becomes Nonfunctional 190 190
Material Frayed 173 173
Migration 167 168
Overheating of Device 163 163
Intermittent Continuity 131 131
Use of Device Problem 129 129
Electromagnetic Interference 121 121
Difficult to Open or Close 117 117
Data Problem 115 115
Patient Device Interaction Problem 113 113
No Apparent Adverse Event 110 111
Loss of Data 91 91
Unintended Application Program Shut Down 81 87
Therapy Delivered to Incorrect Body Area 73 73
Positioning Problem 72 72
Application Program Problem 66 66
Difficult to Remove 57 57
Device Damaged Prior to Receipt by User 46 46
No Device Output 45 45

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10089 10095
Insufficient Information 1625 1627
Unspecified Infection 1241 1242
Movement Disorder 896 904
Shaking/Tremors 830 831
Inadequate Pain Relief 826 831
Failure of Implant 793 802
Ambulation or Postural Difficulties 432 432
Electric Shock 431 431
Erosion 392 394
Pain 317 317
Post Operative Wound Infection 263 265
Discomfort 261 261
Fall 252 252
Swelling/ Edema 243 243
Cognitive Changes 221 221
Dysphasia 215 215
Intracranial Hemorrhage 212 212
Wound Dehiscence 201 201
Bacterial Infection 189 189
Muscular Rigidity 180 180
Convulsion/Seizure 167 167
Burning Sensation 138 138
Paresthesia 137 137
Implant Pain 130 130
Purulent Discharge 128 128
Erythema 128 128
Undesired Nerve Stimulation 127 127
Fluid Discharge 111 113
Headache 106 106
Dyskinesia 104 104
Unspecified Nervous System Problem 99 99
Hematoma 92 93
Pocket Erosion 91 91
Muscle Weakness/Atrophy 90 90
Stroke/CVA 88 88
Confusion/ Disorientation 86 86
Twiddlers Syndrome 81 81
Cramp(s) /Muscle Spasm(s) 80 80
Loss of consciousness 77 77
Impaired Healing 77 77
Scar Tissue 71 71
Skin Erosion 70 70
Inflammation 69 69
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 69 69
Hemorrhage/Blood Loss/Bleeding 68 68
Numbness 59 59
Dizziness 58 58
Device Overstimulation of Tissue 54 54
Dysphagia/ Odynophagia 48 48

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Medical II Nov-07-2025
2 Abbott Medical II Jul-25-2024
3 Abbott Medical II Jul-03-2024
4 Medtronic Neuromodulation II May-28-2026
5 Medtronic Neuromodulation II Oct-23-2024
6 Medtronic Neuromodulation II Jul-24-2024
7 Medtronic Neuromodulation II Nov-03-2023
8 Medtronic Neuromodulation II Oct-18-2023
9 Medtronic Neuromodulation II Apr-19-2023
10 Medtronic Neuromodulation II May-24-2022
11 Medtronic Neuromodulation II Dec-27-2021
12 Medtronic Neuromodulation II Nov-24-2021
13 Medtronic Neuromodulation II Nov-04-2021
14 Medtronic Neuromodulation II Apr-07-2021
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